None listed
Conditions
Interventions
The investigation medicinal product (IMP) to be tested in this study is ESL, presented as 800 mg divisible tablets.
ESL will be administered orally once daily. The first target dose in the open-lab
Sponsors
BIAL - Portela & Cª, S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For inclusion in the extension study, subjects must fulfill all of the following at Visit 1 (Day 1, start of the open-label extension study): 1. Participated in the preceding double-blind study and were still ongoing at the time of unblinding. 2. Have signed informed consent before undergoing any activities related to the open-label extension study. 3. Demonstrated cooperation and willingness to complete all aspects of the study. 4. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study Visit (PSV).
Exclusion criteria
Exclusion criteria: 1. Excluded from the double-blind study due to seizure in the Maintenance or Extension Phase, or at dose level C (either CBZ-CR or ESL), or discontinued prematurely due to any other reason in the double-blind study. 2. Presence of any major protocol violation during the double-blind study which may have an impact on the compliance during this extension study. 3. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS). 4. Occurrence of an adverse event (AE) indicating a suspected presence of atrioventricular block (2nd degree and above) or of any other AEs during the double-blind study which are judged by the investigator as contraindicative to further participation in the open-label extension study. 5. Events of alcohol, drug, or medication abuse during the preceding double-blind study. 6. Relevant clinical laboratory abnormalities (e.g. sodium 2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (as reported at Visit 1). 7. Pregnancy or lactating. 8. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the extension-study protocol.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Israel, Italy, Latovia, Lithuania, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Ukraine, United Kindgdom
Contacts
Public ContactNicolas Sandoval
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed